Severe diabetic foot ulceration and gangrene
Conditions
Interventions
Biococktail tissues generation with investigational devices
Coverage of wounds with the generated biococktail tissues
Sponsors
Aihara Yukiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with type 1 or type 2 diabetes mellitus 2.Patients with foot ulcers or gangrene (excluding venous stasis ulcers) 3.Patients who, at the time of enrollment, meet the following WIfI classification criteria: Wound grade 2-3, Ischemia grade 0-2, and Foot infection grade 0-3, with Clinical stage of 3 or 4 4.Patients who, at the time of enrollment, are expected to have full-thickness skin defects with exposed tendon, muscle, bone or joint. The anticipated post-debridement wound area must be at least 4 cm2 for heel-only wounds or at least 15 cm2 for wounds at other sites, and no larger than 50 cm2 overall. 5.Patients who, at the time of informed consent, are expected to survive for at least 12 months and be available for follow-up for 12 weeks after biococktail tissues coverage
Exclusion criteria
Exclusion criteria: 1.Patients in a general condition that makes it difficult to maintain the implantation period required for biococktail tissues formation using the investigational device 2.Patients with severe malnutrition (CONUT score of 8-12) or serious comorbidities that are considered to make the investigational device implantation difficult 3.Patients judged to be unsuitable for implantation due to poor skin condition or a history of subcutaneous implant exposure 4.Patients who have undergone invasive surgery within 14 days prior to enrollment, except for procedures related to wound care or revascularization 5.Patients with a known allergy to stainless steel or plastic 6.Patients with poorly controlled diabetes, defined as a fasting blood glucose level of 200 mg/dL or higher 7.Patients who have participated in another clinical trial involving investigational drugs or interventions within 3 months prior to enrollment 8.Patients with a history of implantation of the investigational device or prior biococktail tissues coverage using the same device 9.Patients receiving immunosuppressive therapy due to autoimmune disease or post-transplant status 10.Patients with active ulcers, gangrene, or sepsis, in whom major amputation is anticipated during the implantation period 11.Patients with severe systemic infections 12.Pregnant women, breastfeeding women, or women who cannot use contraception during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieved a wound area reduction of 50 percent or more Rate of wound area reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints 1.Occurrence of adverse events 2.Occurrence of investigational device and biococktail tissues malfunctions 3.Occurrence of infections associated with investigational device and biococktail tissues coverage Efficacy endpoints 1.Technical success rate 2.Proportion of subjects with biococktail tissues formation 3.Assessment of wound area 4.Clinical stage according to the WIfI classification 5.Quality of life score 6.Proportion of subjects with complete wound healing | — |
Contacts
Public ContactAkira Wakamatsu
University of Tsukuba
Outcome results
None listed